Catalog Number EUP2515X |
Device Problems
Burst Container or Vessel (1074); Packaging Problem (3007); Physical Resistance/Sticking (4012)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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One euphora rx balloon catheter was intended to be used to treat a non remarkable lesion.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was not performed.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.It was reported that the balloon burst upon inflation inside the lesion.No patient injury is reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product analysis summary: the balloon returned with no blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, a leak was observed on the balloon working length.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a longitudinal tear on the entire working length of the balloon material.The balloon material was jagged and uneven at the tear site.Lead in scratches were evident proximal to the tear site.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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